Food - FDA Learning Cache https://fdalearn.com FDA Learning Resources Curated for Easy Access Fri, 08 Aug 2025 15:05:32 +0000 en-US hourly 1 https://wordpress.org/?v=6.9.4 https://fdalearn.com/wp-content/uploads/2025/04/cropped-FDALearn-Icon-01-2-32x32.jpg Food - FDA Learning Cache https://fdalearn.com 32 32 Kennedy’s Crusade Against Food Safety Rule Threatens Supplement Industry https://fdalearn.com/kennedys-crusade-against-food-safety-rule-threatens-supplement-industry/ https://fdalearn.com/kennedys-crusade-against-food-safety-rule-threatens-supplement-industry/#respond Wed, 06 Aug 2025 15:03:57 +0000 https://fdalearn.com/?p=2515 Article Summary: In his first weeks as health secretary, Robert F. Kennedy Jr. has declared war on the “generally recognized as safe” (GRAS) regulatory process. This obscure pathway allows food companies to introduce new ingredients or chemicals into products without FDA review, as long as they self-certify the items as safe. Kennedy has described GRAS… Read More »Kennedy’s Crusade Against Food Safety Rule Threatens Supplement Industry

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In his first weeks as health secretary, Robert F. Kennedy Jr. has declared war on the “generally recognized as safe” (GRAS) regulatory process. This obscure pathway allows food companies to introduce new ingredients or chemicals into products without FDA review, as long as they self-certify the items as safe. Kennedy has described GRAS as a “loophole” that needs to be eliminated, arguing it has led to thousands of untested ingredients flooding the American food system.

However, the elimination of GRAS would also impact the growing supplement industry, which has regularly used the pathway to quickly bring new ingredients to market with little oversight. Supplement makers are worried they could become “collateral damage” in Kennedy’s campaign targeting unhealthy foods. They have intensely lobbied the FDA, concerned the changes could limit consumer choice in supplements.

Kennedy himself has been an avid supporter of supplements, promising to end the “aggressive suppression” of vitamins and dietary supplements. Many in his circle have ties to the supplement industry, further complicating the matter.

The fight highlights a tension in Kennedy’s movement as it wields power in Washington – the desire to restrain predatory industries, while easing government oversight of alternative health practices. How this plays out remains unclear, but the GRAS designation has provided a “wild west” loophole for supplement makers to bypass more stringent safety requirements. This could be a “litmus test” for how seriously the administration tackles the problems with GRAS.

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]]> https://fdalearn.com/kennedys-crusade-against-food-safety-rule-threatens-supplement-industry/feed/ 0 This Week at FDA: Expert Panels Draw Criticism, HHS Seeks to Define Ultra-Processed Foods https://fdalearn.com/this-week-at-fda-expert-panels-draw-criticism-hhs-seeks-to-define-ultra-processed-foods/ https://fdalearn.com/this-week-at-fda-expert-panels-draw-criticism-hhs-seeks-to-define-ultra-processed-foods/#respond Fri, 25 Jul 2025 21:45:15 +0000 https://fdalearn.com/?p=2369 Article Summary: The FDA has faced criticism over several recent expert panel meetings, which do not require the same level of scrutiny as traditional advisory committees. Concerns have been raised that the panelists were hand-picked by the FDA Commissioner and did not have to provide public briefing documents or give adequate notice for public engagement.… Read More »This Week at FDA: Expert Panels Draw Criticism, HHS Seeks to Define Ultra-Processed Foods

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The FDA has faced criticism over several recent expert panel meetings, which do not require the same level of scrutiny as traditional advisory committees. Concerns have been raised that the panelists were hand-picked by the FDA Commissioner and did not have to provide public briefing documents or give adequate notice for public engagement. For example, an expert panel on the effects of antidepressants during pregnancy was dominated by members who are skeptical of the drugs, some of whom profit from that skepticism. Another panel on oral fluoride supplements included Health and Human Services Secretary Robert Kennedy Jr., who has advocated for removing fluoride from water.

Senators have reintroduced a bill to increase transparency of federal advisory committees by codifying the collection and public release of information about them. Meanwhile, the FDA Commissioner and CDC Director have written that they prefer to negotiate with industry to persuade them to adopt policies voluntarily rather than force those policies through rulemaking. The Commissioner has also reinstated about a quarter of the staff who were fired under the Trump administration.

The FDA’s new Elsa artificial intelligence assistant has been found to have limitations, unable to access relevant documents or fully answer basic questions. The acting director of the FDA’s Digital Health Center of Excellence is also leaving the agency. Separately, the FDA, HHS, and USDA are seeking public input on how to define ultra-processed foods.

In drug and medical device news, the FDA has extended the review period for a non-hormonal menopause drug, while Sarepta Therapeutics will need to conduct a new study for its Duchenne muscular dystrophy drug. The agency has also recalled certain ventilator systems and surgical staplers due to safety concerns.

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